By Nicholas Borgert
The impact of new California laws on the handling and labeling of biological specimens won’t be fully felt until later this year but most labs, doctors and couriers are already taking steps to comply.
“Use of lock boxes is not a new thing,” said David Miles, whose Duramark Inc. is one of the first suppliers of the warning-label compliant lock boxes.
“Generally, we’ve seen a lack of awareness. Lab purchasing people and couriers don’t know about it and haven’t been told about it.” The stricter regulations are aimed at assuring the integrity of specimens and increasing the protection of the public from possible contamination.
Karen Nickel, Ph.D., California’s chief of Lab Field Services, said her department is developing forms for compliance and the reporting of unsecured specimen boxes. Full implementation of the new laws should come by the end of the year.
Physicians especially, Nickel said, have expressed concerns about possible sanctions. “They wonder what would happen if someone in their office sends out an unsecured box,” Nickel said. “We’re working with the California Medical Association to reach out to labs and doctors to explain the forms and procedures.”
Mischief leads to legislation
In 1999, four Burbank, Calif., youths found medical specimens and samples inside an unlocked metal box and plastic foam cooler in the parking lot of a medical building. The specimens were awaiting pickup by a lab courier. The youths dumped the samples of blood, urine, pap smears and biopsied tissue on the ground, broke vials and intermixed blood samples. One even took a blood vial home. Biological materials ended up on the youths’ hands and clothing, exposing them to possible HIV, hepatitis B or other infectious disease. Fortunately, no one was infected.
Officials in Burbank never charged the youths because neither the city nor the state had laws regulating storage and security of the specimens. The California lock box law took effect 13 months ago. The lock box warning label provision became law January 1.
All licensed healthcare professionals who collect human biological specimens for clinical testing are required to secure them in a locked container when placed in a public location, the law mandates. A “Caution: Biohazardous Material — Please Do Not Touch Or Handle” label must be attached to the container. Boxes must be fully enclosed and secured using a padlock, key lock, combination lock or other locking device. Violators can be fined up to $1,000.
Duramark’s biohazard-labeled lock boxes warn potential pranksters of the dangerous specimens within.
Duramark’s Miles estimates that more than 90 percent of state laboratories already had been using lock boxes to store specimens, although some didn’t carry the warning label. Traditionally, he said, courier services have not been as heavily regulated (by DOT and air transport’s IATA) as others. “The labeling is a good idea but only if the laboratory fleets and the contract couriers they use know about it,” Miles said.
Duramark officials anticipate a solid increase in sales of the warning label-compliant containers. A family-owned business now in its second decade, Duramark was founded by Allen H. Miles, a veteran of 30 years in the hospital and laboratory industries. Its products include metal and plastic thermally-efficient lock boxes, OSHA standard courier totes, FDA-certified biohazard clean-up kits, centrifuges and benchtop lab equipment.
Christopher Bader is manager of materials and utilization at Quest Diagnostics, the country’s largest clinical laboratory network. Quest owns and operates a private fleet for retrieving biological specimens from client facilities. According to Bader, the courier pick-up system has been in effect for many years and he traces its beginnings to the days when milkmen performed regular pickups and deliveries.
Bader said Quest used lock boxes to secure specimens long before the recent California laws. The lab has since fully complied with the required labeling. “We made a design change in our lock boxes and did it nationally,” he said. “Kids are always going to be pranksters. Cost was not a consideration. Ultimately, we did not want a reoccurrence of what happened there [in Burbank].”
Typically, laboratories provide free lock boxes to their customers. Specimen integrity is a paramount concern. “They spend a lot of money protecting specimens from the effects of time and temperature,” Miles said. “They don’t want to see the specimens compromised; they don’t want to have to do them again.”
LabCorp maintains a fleet of over 3,000 vehicles, a substantial number of them to service their customers in California. “We are familiar with the laws and will comply,” said Pam Sherry, LabCorp vice president. “They won’t have a huge cost, but they will require some additional paperwork. They will not have a material impact on our operations.”
Sometimes no amount of laws and regulations can prevent the worst abuse in lab testing — total disregard for patient well being. Consider a recent case in North Carolina. Steve Alsop operates Biohazard Response Team, a Charlotte-based firm that specializes in cleaning up bloody crime scenes and other biohazardous environments.
Eight or 10 times a year, Alsop is summoned to car auctions to dispose of used syringes that show up in the cars. Last fall’s trip was different.
Inside a 1996 Ford sedan he found a biohazardous bonanza — used syringes and blood vials spread across the front seat, back seat, floorboard and trunk. Twenty to 30 specimen packages had been neatly marked for overnight shipping, he said, but never were sent. The vehicle had apparently been repossessed from a field nurse working in Virginia.
One auction employee, who was stuck by a syringe under the front seat of a car, faces 10 years of costly testing. Dozens, perhaps hundreds of patients had their specimens rendered unusable and had to undergo additional lab work. The lab delay could have had serious impact on their health.
For Alsop, the lesson is simple: “Make sure you use certified professionals who know and comply with the applicable laws at all times.”
Nicholas Borgert is a freelance writer based in Charlotte, N.C.
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